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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Osseointegration Quality Registry PAS


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General
Study Status Study Pending
Application Number P190009 / PAS002
Date Current Protocol Accepted  
Study Name Osseointegration Quality Registry PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this study is to investigate the 2-year and 5-year safety and effectiveness outcomes of the OPRA device.

The Osseointegration Quality Registry is a prospective registry sponsored by Walter Reed and conducted at all sites that consent to collect data for the registry. The registry study initiated on February 11, 2019 and is sponsored by the Walter Reed. The sponsor of the registry has agreed to provide the OPRA-related data to Integrum, who will analyze the data consistent with FDA’s requested endpoints and then submit reports to the agency. The other PAS, Transfemoral Amputation Osseointegration Study (TFAOS), is a 2-year study. Patients who agree to be followed for 5 years after completion in TFAOS will be transitioned to this registry.



Study Population Description Patients who have the OPRATM implant procedure and meet the eligibility criteria. The study is being conducted at Walter Reed and is offered to all US sites that perform the OPRA implant procedure.
Sample Size 100 subjects will be enrolled in the PAS registry. Up to 50 subjects will be from the other PAS study, TFAOS.

The sample size in the TFAOS study was calculated to power the primary endpoint in that study, which is the change in prosthetic use score.

A sample size of 100 patients is also sufficient for the primary endpoints in the PAS analysis. With an alpha of 0.05, 100 subjects have >98% power to demonstrate that each primary endpoint result will be greater than 50%, assuming 70% success and a power of 86% assuming 65% success.



Data Collection Primary Endpoints

1. Rate of overall success at 2 years and 5 years. The overall success is the composite primary safety and effectiveness endpoint.

a. Primary safety endpoint: Proportion of patients with no subsequent secondary surgical interventions and, at most, 2 superficial infections, at 2 years. and, no subsequent secondary surgical interventions and at most 3 superficial infections at 5 years.

b. Primary effectiveness endpoint: Proportion of patients who achieve the minimally clinically important difference (MCID) for the total Q-TFA score (mean of all subscores, i.e., prosthetic use score, prosthetic mobility score, problem score, and global score) of 20.25 points, and radiographic success, defined as no radiographic loosening of the implant with a radiolucent zone wider than the thread depth surrounding the entire implant.

2. Proportion of patients who achieved either/or/none of primary safety endpoint or primary effectiveness endpoint at 2 and 5 years.



Secondary Endpoints

Proportion of patients who achieved the MCID for the Q-TFA prosthetic use score (19 points), prosthetic mobility score (11 points), problem score (-23 points), and global score (33 points), individually at 2 and 5 years after stage-2 surgery.

Change in each of total Q-TFA score, Q-TFA prosthetic use score, prosthetic mobility score, problem score and global score from baseline to 2 years after stage-2 surgery.

Follow-up Visits and Length of Follow-up 5 years after stage-2 surgery


Osseointegration Quality Registry PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Six month report 06/18/2021   Overdue
One year report 12/18/2021    
18 month report 06/18/2022    
Two year report 12/18/2022    
Three year report 12/18/2023    
Four year report 12/17/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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